Medical food is specially formulated food that meets the nutritional requirements of a specific disease. The FDA defines medical food as ‘food that is formulated to be consumed or administered enterally under the supervision of a physician and that is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation.’ These criteria were defined in FDA’s 1988 Orphan Drug Act Amendments and are subject to the general food and safety labelling requirements of the Federal Food, Drug, and Cosmetic Act.

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